BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50- avobenzone,homosalate,octisalate,octocrylene,and oxybenzone cream

BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 by

Drug Labeling and Warnings

BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.00%

Homosalate 5.00%

Octisalate 5.00%

Octocrylene 2.70%

Oxybenzone 3.00%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For External use only

Do Not Use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses

children under 6 months of age:
ask a doctor

Inactive Ingredients

WATER\AQUA\EAU,BUTYLOCTYL SALICYLATE,METHYL TRIMETHICONE,NEOPENTYL GLYCOL DIHEPTANOATE,ALEURITES MOLUCCANA (KUKUI) SEED OIL,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,PEG-100 STEARATE,BUTYLENE GLYCOL,GLYCERYL STEARATE,DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE,LAMINARIA OCHROLEUCA EXTRACT,LAMINARIA DIGITATA EXTRACT,ALGAE EXTRACT,LAVANDULA ANGUSTIFOLIA (LAVENDER),PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL,SODIUM HYALURONATE,CAFFEINE,ERGOTHIONEINE,SORBITOL,ETHYLHEXYLGLYCERIN,POTASSIUM CETYL PHOSPHATE,CETYL ALCOHOL,VP/EICOSENE COPOLYMER,SACCHARIDE ISOMERATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,CAPRYLYL GLYCOL,AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,STEARIC ACID,DEHYDROXANTHAN GUM,SODIUM DEHYDROACETATE,DISODIUM EDTA,PHENOXYETHANOL,CITRIC ACID,CITRONELLOL,GERANIOL,LINALOOL,MICA <ILN39524>

Other Information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

BOBBI
BROWN

Primer Plus Protection
BROAD
SPECTRUM
SPF 50

1.4 FL. OZ/40 ML e

INGREDIENTS AND APPEARANCE

BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 
avobenzone,homosalate,octisalate,octocrylene,and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
GERANIOL (UNII: L837108USY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
KUKUI NUT OIL (UNII: TP11QR7B8R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-100 STEARATE (UNII: YD01N1999R)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
CAFFEINE (UNII: 3G6A5W338E)
SORBITOL (UNII: 506T60A25R)
CETYL ALCOHOL (UNII: 936JST6JCN)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-035-01	1 in 1 CARTON	08/18/2023
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/18/2023

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(64141-035)